Post-operative Ileus and Gut Microbiota

NCT ID: NCT04009954

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-12-31

Brief Summary

Postoperative ileus (POI) is a common clinical condition after abdominal surgical procedure, leading to increased patient morbidity and prolonged hospitalisation.The mechanism of POI is not very clear until now. At the end of the 20th century, the inflammatory-mediated ileus hypothesis was introduced. But the initial trigger of the inflammatory cascade is unclear.Previous study demonstrate a clear association between colonic transit time, gut microbiota composition and urinary metabolic phenotype. Here the investigators suggest that the perioperative gut microbiota may contribute to POI.

Detailed Description

Postoperative ileus (POI) is a common clinical condition after abdominal surgical procedure, leading to increased patient morbidity and prolonged hospitalisation.

The clinical manifestations include abdominal distension, nausea, vomiting and the inability to pass stools or tolerate a solid diet. In addition to the discomfort experienced by patients, postoperative ileus is also an important risk factor for complications such as wound dehiscence and pulmonary and thromboembolic complications. Ileus was found to be an important predictor of extended postoperative hospital stays and costs in patients undergoing colectomy.

The mechanism of POI is not very clear until now. At the end of the 20th century, the inflammatory-mediated ileus hypothesis was introduced. But the initial trigger of the inflammatory cascade is unclear The innate immune system recognises two large classes of macromolecules: first, those related to pathogens or pathogen-associated molecular patterns (PAMPs), and secondly, molecules released in response to cell damage or damage-associated molecular patterns (DAMPs). The prototype of PAMPs is lipopolysaccharide (LPS), a constituent of the Gram-negative bacterial cell wall. Translocation of microbial products into the intestinal tissue is a well-documented feature in POI. Previous study demonstrate a clear association between colonic transit time, gut microbiota composition and urinary metabolic phenotype. Here the investigators suggest that the perioperative microbiome may contribute to POI. This study apply NGS(next generation sequencing) technique to analyse the composition of the perioperative gut microbiota of CRC(colorectal cancer) patients, then analysis the relationship between the dynamic variation of gut microbiota and POI.

Conditions

Post-operative Ileus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Delayed transit

CRC patients with delayed gut transit recovery( first time defecation \>3 day )

Fecal and blood samples collection for analysis

Intervention Type: OTHER

Fecal sample analysis will consist of the following procedure : Microbial DNA extraction, amplicon library construction, sequencing and analysis; Clustering "MiSeq" reads into operational taxonomic units (OTUs).

Normal transit

CRC patients with normal gut transit recovery( first time defecation \<=3 day )

Fecal and blood samples collection for analysis

Intervention Type: OTHER

Fecal sample analysis will consist of the following procedure : Microbial DNA extraction, amplicon library construction, sequencing and analysis; Clustering "MiSeq" reads into operational taxonomic units (OTUs).

Interventions

Fecal and blood samples collection for analysis

Fecal sample analysis will consist of the following procedure : Microbial DNA extraction, amplicon library construction, sequencing and analysis; Clustering "MiSeq" reads into operational taxonomic units (OTUs).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Requirements of informed consent and assent of participant, parent or legal guardian as applicable
• Patients with colorectal cancer scheduled for radical coloproctectomy and between the age of 35 and 80 years old without considering sex.
• Patients with BMI= 18.5-23.9

Exclusion Criteria

• Patients with colorectal cancer with distant metastasis
• Chronic renal diseases and hepatic cirrhosis
• Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months
• Individuals with a history of Chronic diarrhea
• Individuals with a history of Diabetes mellitus
• Individuals with a history of Hypertension
• Individuals with a history of autoimmune diseases
• Use of antibiotics and probiotics 3 mouth before samples collection
• Individuals with a history of abdominal operation due to any reason
• Individuals with any history of cancer other than colorectal cancer
• Individuals with Inflammatory bowel disease

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yunwei Wei

Role: STUDY_DIRECTOR

First Affiliated Hospital of Harbin Medical University

Locations

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunwei Wei, professor

Role: CONTACT

hydwyw11@hotmail.com

+86045185553099

Yang Liu, assistant research fellow

Role: CONTACT

lyang712@icloud.com

+8618345180169

Facility Contacts

Yunwei Wei

Role: primary

hydwyw11@hotmail.com

+86-0451-85553099

Other Identifiers

Yunwei Wei 2019-04-19

Identifier Type: -

Identifier Source: org_study_id